Journal of Clinical and Translational Science最新文献

Introduction: Traumatic brain injury (TBI) is a leading cause of disability and death. Both repetitive transcranial magnetic stimulation (rTMS) and Cerebrolysin (CRB) are promising therapies regulating neural plasticity. This study aimed to assess the changes in resting-state brain activity following CRB, rTMS, or combined CRB-rTMS therapy.

Methods: This secondary analysis of the CAPTAIN-rTMS trial analyzed eyes-closed segments from EEG recordings at 30 days (baseline) and 180 days (after treatment) respectively. We computed relative power spectral densities for delta, theta, alpha and beta frequency bands, for the entire scalp and different regions. We conducted neuropsychological assessments and evaluated the correlations between resting-state relative power spectral density values and neuropsychological assessment performance.

Results: We analyzed a total of 50 patients. For the entire scalp, we found statistically significant decreases in relative alpha power (p = 0.02) and significant increases in relative delta power (p = 0.02), further subgroup analysis showing differences between visits in the CRB + sham group (paired Cliff's δ = 0.6, p = 0.012 for Delta band, δ = 0.6, p = 0.064 for Alpha band). The differences were higher in the central (alpha p = 0.004, delta p = 0.002) and parietal (alpha p = 0.012, delta p = 0.03), and lower in the frontal (alpha p = 0.05, delta p = 0.026), temporal (alpha p = 0.065, delta p = 0.077), and occipital (alpha p = 0.064, delta p = 0.084) regions. Neuropsychological tests performance was negatively correlated with resting-state relative delta power, and positively correlated with alpha power.

Conclusion: We found overall slowing of brain electrical activity during recovery after TBI, which was further influenced by rTMS and CRB treatment. Resting-state relative power spectral densities correlate with neuropsychological measurements.

Background: IMARA-South Africa (SA) is an HIV/STI prevention program for adolescent girls and young women (AGYW) and their female caregivers (FC). We examined six implementation outcomes of IMARA-SA (acceptability, appropriateness, feasibility, reach, adoption, and sustainability) from the perspectives of study staff, investigators, and collaborators.

Methods: We used a sequential explanatory mixed-methods design. We administered surveys, hosted three focus group discussions with study staff/facilitators (n = 5), clinic staff (n = 3), and community advisory board members (n = 5), and conducted seven key informant interviews with investigators and study staff. We used descriptive statistics and rapid qualitative analyses, merging quantitative and qualitative data by implementation outcome to achieve triangulation.

Results: On 27 surveys analyzed, mean scores were highest for acceptability (2.8/3, SD = 0.6), appropriateness (2.7/3, SD = 0.5), and reach (2.7/3, SD = 0.5), followed by feasibility (2.1/3, SD = 0.5), adoption (3.8/5, SD = 0.3), and sustainability (5.9/7, SD = 0.8). All perceived the AGYW and FC to love the program, which fit well with South African culture and addressed AGYW's needs. The delivery site was deemed highly appropriate for reaching vulnerable populations. The lowest scoring items concerned time constraints (2.2/3, SD = 0.9), safety concerns (1.4/3, SD = 0.7), complexity (2.9/5, SD = 1.3), and cost (2.8/5, SD = 0.9). Qualitative participants attributed complexity and cost challenges to the research procedures, not the intervention. Participants proposed potential avenues for future implementation (e.g., schools, clinics) and interest in engaging males.

Conclusion: IMARA-SA is implementable. Findings reveal challenges with navigating trade-offs between implementation outcomes and surveys distinguishing between intervention and research activities. Findings can inform future delivery of IMARA-SA and similar programs regionally.

Introduction: The conduct of Clinical and Translational Research (CTR) requires the engagement of highly effective collaborative teams. Clinical and Translational Science Award hubs have employed team-building strategies to improve team processes and interpersonal relationships in CTR teams. As previously reported, the University of Wisconsin Institute for Clinical and Translational Research (UW-ICTR) team science core operationalized and implemented one such strategy: Collaboration Planning. Here, we report on optimization of that intervention and assessment of three outcomes: (1) Changes in clarity and confidence around team processes; (2) Value and usefulness; and (3) Plans for future behavior change.

Materials and methods: Collaboration Planning 2.0 improves upon our initial implementation by (1) optimizing the worksheet for flow, accessibility, and deeper discussion; (2) expanding the evaluation process; and (3) creating a facilitator training to support broad dissemination. We tested this iteration in 11 UW-ICTR pilot teams using pre- and post-session self-assessment surveys.

Results: Data indicated an increase in participants' clarity and confidence around all measured team processes except authorship. Ninety-one percent of participants found the intervention both valuable and useful. Participants indicated plans for future behavior change, including increased attention to team processes. To date, more than 400 individuals have completed the Collaboration Planning Facilitator Training, indicating a deep need in the community for tools for effective team-focused interventions.

Conclusion: These results provide evidence that Collaboration Planning is an effective, accessible, low-barrier intervention for improving team processes and interpersonal relationships in CTR teams. Future work includes expanded evaluation, greater personalization of the intervention, and self-administered facilitation.

Assessing the long-term impact of community-engaged research (CEnR) programs remains a significant challenge in translational science, such as those conducted by Clinical and Translational Science Awards (CTSAs). The Translational Science Benefits Model (TSBM) is a framework designed to evaluate impact across four health and social domains (clinical/medical, community, economic, and political/legislative). TSBM offers a comprehensive framework for evaluating CEnR projects, as it extends beyond short-term outcomes to highlight distal impacts and sustainable benefits. Progress reports from three Cincinnati CTSA CEnR programs (Community Leaders Institute [CLI; n = 170], Community Health Grant [CHG; n = 82], and Partnership Development Grant [PDG; n = 21]) completed between 2010 and 2023 were coded by three reviewers using the TSBM. As expected, CEnR programs primarily demonstrated community & public health benefits. Economic, policy, and clinical benefits were also identified, further amplifying the impact of this work. The adoption of frameworks like the TSBM could lead to a more standardized approach for evaluating the impact of CEnR programs and facilitate comparisons across CTSAs. Future studies that track the impact of CEnR programs on health and social systems could provide valuable insights into the long-term benefits of these initiatives.

Background: Digital tools offer promising solutions to improve eligibility screening, recruitment, and retention in research, particularly in human genetic studies where representative sampling is critical. SMS text messaging has been found effective in population-based survey research, but evidence of its impact on genetic study recruitment - and how it varies by demographics - is limited.

Objective: We examined the effect of tailored SMS messages on enrollment in a population-based genomic screening study. We assessed differences in message open and consent rates across four message types and explored how these outcomes varied by demographic factors.

Methods: Participants were randomized to receive one of four SMS messages emphasizing different social values: generic, individual impact, community impact, or research discoveries. We calculated descriptive statistics for open and consent rates and used generalized linear logistic regression and Pearson's Chi-Square Test to assess demographic differences.

Results: Among 15,977 messages sent, 2.4% were opened (n = 382), and 35.3% of those who opened consented (n = 135). Females were more likely than males to open (3.1% vs. 1.6%) and consent (1.1% vs. 0.5%). Individuals aged 30-39 had the highest open rate (3.4%), and those 40-49 had the highest consent rate (1.6%). Message type was not significantly associated with open or consent rates.

Conclusion: Sociodemographic factors were more predictive of engagement than message content. Tailoring messages by demographic group may improve recruitment in genomic studies. Future research should explore the drivers of participant engagement in digital recruitment strategies.

Background: Numerous efforts are focused on building the clinical and translational research (CTR) workforce. Approaches to evaluate CTR initiatives are varied, and efforts often rely on research project-level outcomes. This article applies an evaluation tool to capture individual-level data.

Objective: The study used a novel Researcher Investment Tool (RIT) to measure researchers' experience as well as perceptions of institutional support, including an analysis based on researcher characteristics. The study also evaluated the RIT based on common measures, including a bibliometric indicator, investigator status, and percent time dedicated to research.

Methods: The RIT was administered to researchers who received funding or targeted research support from a CTR initiative. Mean scores were assessed by RIT section, domains/sub-domains, and for each item. Mean scores per section were compared across researcher characteristics using t-tests, and associations between common measures and average domain scores were tested using linear regression.

Results: Thirty researchers completed all RIT items. RIT domain scores ranged from a high mean of 4.0 for the research skills domain to a low mean of 2.6 for researcher productivity and community engagement domains. Analysis of indicators of commonly used measures across domains suggest that researchers with a higher bibliometric score had more advanced research skills, service to profession, research productivity, and research collaboration (p < .05). New investigators had lower perceptions of institutional support (p < .05).

Conclusions: As an evaluation tool, the RIT captures individual-level data that may help to determine key areas of strength and opportunities for growth of a CTR program.

This report outlines the workflow, challenges, and key roles involved in operationalizing a complex, disruptive, acute clinical trial protocol requiring multidisciplinary collaboration. Yale University School of Medicine and the Neuroscience Intensive Care Unit (NICU) at Yale New Haven Hospital (YNHH) leverage interdisciplinary collaboration to successfully enroll patients into complex clinical trials, including the Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) trial (ClinicalTrials.gov identifier: NCT05020535). Successful execution of the BEACH trial relies on five key domains: ensuring patient safety, optimizing screening and enrollment, acquiring pharmacokinetics, identifying signals of efficacy, and adapting to operational challenges. These domains require precise coordination, communication, and adaptability within dynamic patient care environments. By streamlining workflows, all members of the care delivery team and the research team maximize efficiency and optimize patient enrollment while upholding the highest standards of ethical research and patient care. Implementation of the BEACH trial at the Yale research center exemplifies the critical role of interdisciplinary collaboration in clinical research. By integrating research into patient care, the team improves trial efficiency and contributes to innovative treatment strategies for intracerebral hemorrhage. Lessons learned can inform best practices for future acute trials and improve patient outcomes.

Introduction: Recruiting and retaining racial/ethnic minorities in research remains a significant challenge, often due to mistrust in clinical research and cultural misconceptions related to specific conditions. Despite the anonymity provided by technology-based intervention studies, difficulties in participant recruitment and retention in these studies remain. This paper addresses practical issues in recruiting and retaining Asian American breast cancer survivors with pain and depressive symptoms in a technology-based intervention study.

Methods: To identify practical issues in participant recruitment and retention, a content analysis was conducted on all recorded materials, including research diaries of individual research team members, weekly team meeting minutes, and research team members' posts on Microsoft Teams.

Results: Analysis identified six practical issues: (a) strict inclusion/exclusion criteria; (b) multiple stigmas associated with cancer, depressive symptoms, and pain; (c) lack of interest in research participation; (d) closed Asian American communities/groups; (e) frequent technological issues; and (f) potential unauthentic cases.

Conclusion: Addressing these recruitment and retention issues can inform the design of future culturally tailored, technology-based intervention studies for racial and ethnic minority populations.